Status:
RECRUITING
Stroke Risk Assessment and Markers of Blood Clotting in Patients With Newly Diagnosed Non-valvular Atrial Fibrillation (NVAF), Who Have Not Received Oral Anticoagulation Therapy (OAC-therapy) Prior to Inclusion
Lead Sponsor:
Nedim Tojaga
Collaborating Sponsors:
Esbjerg Hospital - University Hospital of Southern Denmark
Karola Jørgensens Foundation and Foundation for Cardiology in Southwest Denmark.
Conditions:
Atrial Fibrillation (AF)
Atrial Fibrillation (Prevention of Stroke)
Eligibility:
All Genders
18+ years
Brief Summary
Background: Atrial fibrillation (AF) is the most common heart rhythm disorder worldwide. Globally, there are 37.5 million people with AF. AF increases the risk of death, heart failure, and stroke, wh...
Detailed Description
Background: Non-valvular atrial fibrillation (NVAF) is the most prevalent cardiac arrhythmia worldwide, and it is associated with a five-fold increased risk of ischemic stroke compared to a healthy p...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed non-valvular atrial fibrillation (NVAF), who are oral anticoagulant-naïve (OAC-naïve) prior to inclusion.
- Age ≥ 18 years.
- Signed informed consent.
Exclusion
- Ongoing OAC treatment prior to inclusion.
- Valvular AF (mechanical heart valves or moderate-severe mitral stenosis).
- Secondary AF due to an acute reversible precipitant (e.g., infection, surgery, thyrotoxicosis, etc.).
- Pregnant or breastfeeding women.
- Treatment with oral contraceptives.
- End-stage renal disease (creatinine clearance \<15 mL/min as calculated by the Cockcroft-Gault equation).
- Connective tissue diseases.
- Active cancer (cancer diagnosis not followed by curative procedures six months from the date of diagnosis).
- Major surgery (\< three months).
- Acute coronary syndrome, stroke/TIA, and venous thromboembolism within three months prior to inclusion.
- Thrombophilia.
- Significant liver disease.
- Significant hematological disease.
Key Trial Info
Start Date :
August 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06949319
Start Date
August 16 2024
End Date
September 1 2025
Last Update
April 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Esbjerg Hospital - University Hospital of Southern Denmark, involving collaboration between the Unit for Thrombosis Research, Department of Clinical Diagnostics and the Department of Cardiology.
Esbjerg, Region Syddanmark, Denmark, 6700